Clinical trial · Interventional
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
NCT03226119CI-TRIAL-00034829completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HTLV I Associated Myelopathies | — | UNRESOLVED | — |
| HTLV I Associated T Cell Leukemia Lymphoma | Adult T-Cell Leukemia/Lymphoma | ALIAS | 0.90 |
| HTLV-II Infections | — | UNRESOLVED | — |
| HTLV-I Infections | — | UNRESOLVED | — |
| Human T-lymphotropic Virus 1 | — | UNRESOLVED | — |
| Human T-lymphotropic Virus 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MP Diagnostics HTLV Blot 2.4 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HTLV Infected (n=50)
- description
- Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)
- interventionNames
- Diagnostic Test: MP Diagnostics HTLV Blot 2.4
- type
- EXPERIMENTAL
- label
- Neurological Disorders (n=100)
- description
- Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica
- interventionNames
- Diagnostic Test: MP Diagnostics HTLV Blot 2.4
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All Specimens: * Male or female * Biorepository specimen de-identified of PHI * Specimen meets HTLV Blot 2.4 labeling collection/handling criteria HTLV Positive Specimens: Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II Neurological Disorders: Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders: * Acute Disseminated Encephalitis * Amyotrophic Lateral Sclerosis (ALS) * Autonomic Dysfunction * Conus Medularis Syndrome * Chronic Inflammatory Demyelinating Polyneuropathy * Dermatomyositis * HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP) * Meningitis * Mild Cognitive Impairment * Multiple Sclerosis (MS) * Polymyositis * Spastic Paraparesis * Sciatica Exclusion Criteria: HTLV Infected: * specimens with a known infection or history of HIV, HCV or HBV * specimens not meeting specimen labeling collection / handling criteria Neurological Disorders * specimens not meeting specimen labeling collection / handling criteria
References
Publications (1)
- BACKGROUNDMiller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11. PMID 26589659